This is a prospective, multi-center, open-label, single-arm, investigator-initiated clinical trial to evaluate the safety and efficacy of oncolytic virus injection (OVV-01) in combination with trained immunity NK (tiNK) cell injection (IBR900) for patients with advanced malignant tumors.
In this study, it is planned to enroll about 6-12 subjects with advanced solid tumors or relapsed/refractory lymphomas who have failed in the third-line or higher standard of care in about 1-3 study sites in China. A 2-dose gradient joint exploratory study using the traditional "3+3" mode is adopted in this study. If the high-dose group does not yet reach the MTD, the investigator and funder will decide whether to continue the dose escalation and whether to add a new dose group. 2 dose gradients are used for the OVV-01 injection, and the total infusion dose of IBR900 cell injection is 4.0×10\^9 cells per cycle. OVV-01 injection will be first administered at W1D1 and then at W4D1 followed by every 2 weeks as a treatment cycle, for a total of 6 doses; after the test in the high-dose group is completed, the investigator and sponsor will determine whether to adjust the dosing frequency of OVV-01 (such as once a week) based on the result evaluations. The IBR900 cell injection will be first administered at W1D3 and W1D5 for 2 infusions, and then at W4D3 and W4D5, followed by every 4 weeks as a cycle, for a total of 4 doses, and cell infusions will be conducted at W1, W4, W8 and W12, respectively.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
2 dose gradients are used for the OVV-01 injection, and the total infusion dose of IBR900 cell injection is 4.0×10\^9 cells per cycle. OVV-01 injection will be first administered at W1D1 and then at W4D1 followed by every 2 weeks as a treatment cycle, for a total of 6 doses; after the test in the high-dose group is completed, the investigator and sponsor will determine whether to adjust the dosing frequency of OVV-01 (such as once a week) based on the result evaluations. The IBR900 cell injection will be first administered at W1D3 and W1D5 for 2 infusions, and then at W4D3 and W4D5, followed by every 4 weeks as a cycle, for a total of 4 doses, and cell infusions will be conducted at W1, W4, W8 and W12, respectively.
Beijing Boren Hospital
Beijing, Beijing Municipality, China
Dose limiting toxicity (DLT)
To evaluate the safety and tolerability of OVV-01 injection and IBR900 cell injection
Time frame: 7 weeks after initial administration
Adverse events (AEs)
The incidence and severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and the correlation between AEs and OVV-01 injection combined with IBR900 cell injection
Time frame: 24 weeks after initial administration
Objective response rate (ORR)
To evaluate the effectivity of OVV-01 injection and IBR900 cell injection
Time frame: Up to 1 year after administration
Progression-free survival (PFS)
To evaluate the effectivity of OVV-01 injection and IBR900 cell injection
Time frame: Up to 1 year after administration
Overall survival (OS)
To evaluate the effectivity of OVV-01 injection and IBR900 cell injection
Time frame: Up to 1 year after administration
Disease control rate (DCR)
To evaluate the effectivity of OVV-01 injection and IBR900 cell injection
Time frame: Up to 1 year after administration
Duration of overall response (DOR)
To evaluate the effectivity of OVV-01 injection and IBR900 cell injection
Time frame: Up to 1 year after administration
Peak plasma concentration of OVV-01
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Blood samples will be collected at specified time points to detect the concentration of OVV-01 in peripheral blood and to evaluate the PK parameters
Time frame: 14 days after the last administration
Peak plasma concentration of IBR900 cells
Blood samples will be collected at specified time points to detect the concentration of IBR900 cells in peripheral blood and to evaluate the PK parameters
Time frame: 16 days after initial administration
Plasma concentration of anti-VSV-G antibody and neutralizing antibody
To observe and evaluate the time, titer, and subject rate of antibody development after administration
Time frame: 16 weeks after initial administration